May 14, 2012 — Stereotaxis Inc. released to the European market the V-Sono intra-cardiac echocardiography (ICE) manipulator module for the Vdrive Remote Navigation System.
Designed to manipulate accessory devices such as variable loop catheters, steerable sheaths, and ultrasound catheters, the Vdrive platform combines magnetic navigation with the Odyssey information management system to bring precise control during catheter-based EP procedures.
The Company also announced the first human case using the V-Sono module has been performed by Dr. Georg Nolker of Herz und Diabeteszentrum Klinik fur Kardiologie in Bad Oeynhausen, Germany, April 30. A patient was treated for a complex left persistent atrial fibrillation and Nolker performed a fully remote intervention, using the Vdrive Duo platform (the V-Loop module for the circular mapping catheter and the V-Sono module for the ICE catheter) in concert with the Niobe ES Magnetic Navigation System.
"Intracardiac echo has been long established to provide patient safety and cardiac visualization without radiation,” Nolker said. “This new robotic control makes intracardiac echo more stable, precise, and easier to use in a way that has not been previously available."
The core components of Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. The V-Loop circular mapping catheter manipulator is currently under regulatory review by the U.S. Food and Drug Administration.
For more information: www.stereotaxis.com